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Kidney NeoplasmsPhase 2NCT00651482

Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)

A Phase 2 study testing Everolimus and Bevacizumab in people with Kidney Neoplasms and Kidney (Renal Cell) Cancer, run by Sandy Srinivas at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Neoplasms, Kidney (Renal Cell) Cancer
What is being tested?
Everolimus and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Aug 2008to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Histologically confirmed metastatic RCC that is predominantly clear cell Measurable disease, as defined by RECIST
  • Age ≥ 18 years
  • ECOG performance status of 0 or 1
  • No more than 1 prior targeted therapy (eg, sorafenib, sunitinib) (prior cytokine therapy allowed)
  • No more than 2 prior systemic therapies
Show all 57Show fewer
  • Ability and capacity to comply with the study and follow-up procedures
  • General Exclusion Criteria
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of < 12 weeks
  • Inadequate organ function, as evidenced by any of the following at screening:
  • Absolute neutrophil count (ANC) < 1500/uL
  • Platelet count ≤ 100 x 10^9/L
  • Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
  • AST and/or ALT > 2.5 x ULN for patients without evidence of liver metastases, or 5 x ULN for patients with documented liver metastases
  • Serum creatinine > 2.0 mg/dL
  • Hemoglobin < 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
  • Active infection or fever > 38.5°C within 3 days of starting treatment
  • Women who are pregnant or breast feeding,
  • Able to conceive and unwilling to practice an effective method of birth control.
  • History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
  • Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Principal Investigator.
  • Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
  • Disease-Specific Exclusion Criteria
  • RCC with predominantly sarcomatoid features
  • Radiotherapy for RCC within 28 days prior to Day 1, with the exception of single-fraction radiotherapy given for the indication of pain control
  • Prior treatment with bevacizumab or any mTOR inhibitor (eg, temsirolimus, sirolimus, or everolimus)
  • Current need for dialysis
  • Bevacizumab-Specific Exclusions
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
  • Significant vascular disease (eg, aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy that is not intentionally pharmacologically-induced
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening as demonstrated by a urine protein:
  • Creatinine (UPC) ratio ≥ 1.0. If UPC ratio ≥ 1.0, the patient must undergo a 24 hour urine collection which must demonstrate ≤ 1g of protein in 24 hours to be eligible.
  • Known hypersensitivity to any component of bevacizumab
  • RAD001-Specific Exclusion Criteria
  • Known hypersensitivity to any component of RAD001
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Severely impaired lung function (spirometry and DLCO < 50% of normal and O2 saturation 88% or less at rest on room air)
  • If O2 saturation is ≤ 88% at rest on screening, pulmonary function tests (PFTs) will be ordered to confirm normal pulmonary function and eligibility.
  • Fasting total cholesterol > 350 mg/dL
  • Fasting triglyceride level > 400 mg/dL or >2.5 x ULN
  • Fasting serum glucose > 250 mg/dL
  • Serum phosphorus < 2.0 mg/dL
  • Serum corrected calcium < 8.0 mg/dL

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer

Being tested
Everolimus, Bevacizumab
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00651482
Study groupRoleWhat they receive
Bevacizumab + RAD001 (everolimus)ExperimentalStudy treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted) Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Receives: Drug: Everolimus; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) per RECIST criteria

    Measured: 24 months

Secondary outcomes (8)

  1. Objective Response (OR)

    Number of subjects with objective response (OR)

    Measured: 24 months

  2. Objective Response (OR) Duration

    Measured: 24 months

  3. Time-to-Treatment Failure (TTF)

    Measured: 24 months

  4. Overall Survival (OS)

    Measured: 44 months

  5. Number of Subjects With Drug-related SAEs

    Measured: 24 months

  6. Total Number of Drug-related SAEs

    Measured: 24 months

  7. Treatment Discontinuation Due to Toxicity

    Number of subjects whose treatment was discontinued due to toxicity

    Measured: 24 months

  8. Treatment Discontinuation Due to Disease Progression

    Number of subjects whose treatment was discontinued due to disease progression

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00651482
Sponsor's protocol ID
IRB-11789
Other IDs
RENAL0016, 98593, AVF4304s, 41839
Status last verified
Mar 2017
First submitted
28 Mar 2008
Last updated
11 Apr 2017
Data monitoring committee
Yes

Publications

  • Harshman LC, Barbeau S, McMillian A, Srinivas S. A phase II study of bevacizumab and everolimus as treatment for refractory metastatic renal cell carcinoma. Clin Genitourin Cancer. 2013 Jun;11(2):100-6. doi: 10.1016/j.clgc.2012.12.002. Epub 2013 Jan 24.

    PubMed 23352238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and Bevacizumab in people with Kidney Neoplasms and Kidney (Renal Cell) Cancer, run by Sandy Srinivas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00651482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.

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Clinical Trial NCT00651482 | AzTrials